Second Forum pilot project on authorisation – final report 1

Final report on the second

Forum pilot project on authorisation

Reporting period: January 2016 – November 2016

Second Forum pilot project on authorisation – final report 2

Disclaimer

This document aims to assist users in complying with their obligations under the REACH

and CLP Regulations. However, users are reminded that the text of the REACH and CLP

Regulations is the only authentic legal reference and that the information in this

document does not constitute legal advice. Usage of the information remains under the

sole responsibility of the user. The European Chemicals Agency does not accept any

liability with regard to the use that may be made of the information contained in this

document.

Forum Final Report on the second Forum pilot project on authorisation

Reference: ECHA-17-R-16-EN

Cat. number: ED-04-17-571-EN-N

ISBN: 978-92-9495-975-1

DOI: 10.2823/332997

Date: June 2017

Language: English: EN

© European Chemicals Agency, 2017

Cover page © European Chemicals Agency

If you have questions or comments in relation to this document please send them (quote

the reference and issue date) using the information request form. The information

request form can be accessed via the Contact ECHA page at:

http://echa.europa.eu/contact

European Chemicals Agency

Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland

Visiting address: Annankatu 18, Helsinki, Finland

Second Forum pilot project on authorisation – final report 3

Table of contents

A. Introduction ................................................................................................... 5

B. Objectives and participants of the project ...................................................... 5

C. Background information ................................................................................. 6

1. Project history and background ........................................................................ 6

2. Legislative background .................................................................................... 6

D. Enforcement actions....................................................................................... 7

1. Participating countries and number of inspections............................................... 7

2. Coordination of the project .............................................................................. 7

3. Methods of enforcement .................................................................................. 8

E. Results and conclusions .................................................................................. 8

1. General overview ...................................................................................... 8

1.1. Overview of the number of inspections .................................................. 8

1.2. NACE codes of the inspected companies ................................................. 9

1.3. Size of the inspected companies ........................................................... 9

1.4. Roles of the inspected companies under REACH .....................................10

2. Number of companies inspected, per substance subject to inspection. ...............10

3. Number of inspected companies placing a substance subject to inspection on the

market after its sunset date. ........................................................................11

4. Number of inspected companies using a substance subject to inspection and

applied exemption ......................................................................................13

5. Number of non-compliances .........................................................................15

6. Number and kind of legal action initiated against the offender ..........................15

7. Number of cases forwarded to other Member States and the identity of the

receiver of the information ...........................................................................15

8. Enforceability of the authorisation decision/succinct summary ..........................15

F. Recommendations ........................................................................................ 16

1. Recommendations to the Forum .................................................................16

2. Recommendations to enforcement authorities and inspectors ........................16

3. Recommendations to industry ....................................................................16

4. Recommendation to the Commission ..........................................................16

List of annexes: ................................................................................................ 16

Annex 1: Responses to question 3.2 of the questionnaire ................................ 17

Annex 2: List of substances included in Annex XIV to REACH ("Authorisation List") with their sunset dates in 2015. ............................................................. 23

Annex 3: Questionnaire on the Forum second pilot project on authorisation .... 24

Second Forum pilot project on authorisation – final report 4

Executive summary

The Forum for Exchange of Information on Enforcement (The Forum) conducted the

second Forum pilot project on authorisation. 17 countries1 participated in the project,

which was limited to checking for the placing on the market and/or use of substances

subject to authorisation with sunset dates that were reached in 2015 and, where

relevant, checking compliance with conditions in granted authorisations.

The project was set up in March 2015. National enforcement authorities (NEAs) from

participating MSs conducted inspections in 2016 (January–October) using the manual and

questionnaire prepared by the Working Group ‘Second pilot project on authorisation’.

The reporting phase took place from November 2016 to February 2017.

The pilot project has been successful. A total of 802 inspections were completed as part

of this project. These are made up of onsite inspections and desktop inspections.

A questionnaire was completed for each substance inspected.

A total of 367 (46 %) of the companies inspected fall into the NACE code category

‘manufacturing of chemicals and chemical products’ (NACE Code 20.00-28.89). Micro,

small and medium-sized companies (SMEs) represented 78 % of the companies

inspected. 20 % of the companies inspected have a downstream user role in the supply

chain (the role of the company is only stated for 25 % of the substances inspected).

The majority of companies inspected did not place substances subject to authorisation

with their sunset dates in 2015 on the market (735). 16 companies placed substances

on the market based on an authorisation granted. 30 companies placed substances

on the market for an exempted use. In addition, 16 companies placed these substances

on the market based on a pending authorisation decision.

The majority of companies inspected did not use substances with their sunset date in

2015 (746). 28 companies used substances where an authorisation had been granted for

their use(s). 13 companies used substances subject to authorisation for an exempted

use. Furthermore, 10 companies used substances with an authorisation decision pending.

In total, 19 non-compliances in reference to Articles 56, 65 or 66 of REACH were found

in 12 cases. Three verbal advices, five written advices and four administrative orders

were issued. In two cases, a criminal complaint/handing over to the public prosecutor’s

office was undertaken. Follow up activities are still on-going for five cases (multiple

responses). Information was forwarded to another MS in three cases for further follow

up.

The Working Group have outlined some recommendations for the Forum, Commission,

enforcement authorities, inspectors and for industry based on the findings of this project.

1 AT, BE, CZ, DK, EE, DE, EL, ES, FI, FR, IE, IT, LI, LT, NL, SE and UK

Second Forum pilot project on authorisation – final report 5

A. Introduction

At the Forum 20 plenary meeting, the Forum decided to engage in a second pilot project

on authorisation. Authorisation is a relatively new legal obligation and national

enforcement authorities (NEAs) need to gain experience in enforcing it.

The Forum’s pilot project on authorisation aimed to check compliance with the REACH

Regulation regarding the placing on the market and use of substances subject to

authorisation with their sunset dates in 2015 (see Annex 2).

This pilot project is a follow-up project to the first pilot project on authorisation (related

to placing on the market or using MDA and Musk xylene). The focus of the project was

on gathering experience and building practice and processes for enforcing authorisation-

related obligations. The project was set up in 2015 with inspections taking place in 2016.

B. Objectives and participants of the project

The scope of the project was to clarify and establish a practical way of enforcing the

authorisation obligations thus building enforcement experiences and practices by

checking compliance with REACH authorisation obligations and, where required, enforcing

non-compliance. The project was restricted to substances subject to authorisation with

their sunset dates in 2015.

This pilot project was targeted to manufacturers, importers and downstream users and

focused on checking for the presence of substances on the market beyond their sunset

dates and in particular on:

Checking that substances with their sunset dates in 2015 (see Annex 2):

- are placed on the market for a use and/or are used only in accordance with

a granted authorisation; or

- where an application has been submitted before the latest application date but not

yet granted; or

- where placing on the market or use is justified by an exemption from the

authorisation requirement.

Checking whether holders of authorisations and “Article 66 notifiers” for substances

with their sunset dates in 2015 comply with authorisation decisions

(see Table 1 and the list of authorisation decisions on the website:

http://ec.europa.eu/growth/sectors/chemicals/reach/about/index_en.htm).

This included checking if the use of a substance is exempted from the authorisation

requirement or is an authorised use. Furthermore, it included checking whether any

conditions and/or monitoring arrangements stipulated in the authorisation decisions

are followed for each authorised use.

The following countries – AT, BE, CZ, DK, EE, DE, EL, ES, FI, FR, IE, IT, LI, LT, NL, SE

and UK – participated in the project, which was conducted from March 2015 until

November 2016.

Second Forum pilot project on authorisation – final report 6

C. Background information

1. Project history and background

This project is integrated in the implementation of several of Forum’s tasks as

established by Article 77(4) of REACH, in particular:

a) spreading good practice and highlighting problems at Community level;

b) proposing, coordinating and evaluating harmonised enforcement projects and joint

inspections;

c) identifying enforcement strategies, as well as best practice in enforcement;

d) developing working methods and tools to be used by local inspectors.

Authorisation obligations fall under one of the strategic priorities of the Forum for 2014-

2018 namely, the focus on enforcing obligations related to the safe use of substances.

The objectives of the project were to:

establish a practical way of enforcing the authorisation obligations thus building

enforcement capacity;

assess the target group’s compliance with REACH provisions on authorisation

through a uniform approach (target group = manufacturers, importers,

downstream users);

investigate the target group’s knowledge of REACH authorisation duties and

advise about its authorisation obligations;

where required, enforce non-compliances with regard to authorisation obligations;

promote cooperation among enforcement authorities and contribute to

harmonised enforcement in the EEA;

foster an information exchange between all enforcement actors at regional,

national and international level;

contribute to further improvement of the capabilities of enforcement authorities;

raise awareness of REACH authorisation obligations.

2. Legislative background

This pilot project on authorisation is limited to the REACH Regulation. Obligations

imposed by the CLP Regulation are not included.

The obligations to be checked and eventually enforced within the scope of this project

were:

Article Description

56(1)(a)56(1)(b),

56(1)(e) 56(3),

56(4), 56(5),

56(6)2

The requirement not to place on the market for a use or use a

substance covered within the scope of authorisation, after the

sunset date unless the use is exempted or an authorisation for that

use has been granted to an immediate downstream user

56(2) The requirement for a downstream user to use a substance subject

to authorisation in accordance with the conditions of an

authorisation granted to an actor up the supply chain for that use

65 The requirement for a holder of an authorisation to include the

2 Additional exemptions apply under Article 2(5) for uses in medicinal products and in food or feeding stuff and

under Article 2(8) for intermediates, see Annex 1.

Second Forum pilot project on authorisation – final report 7

authorisation number on the labels

66(1) The requirement for downstream users using a substance in

accordance with Article 56(2) to notify ECHA within three months

of the first supply of the substance

D. Enforcement actions

1. Participating countries and number of inspections

17 Member States3 participated in the project, which was limited to substances subject to

authorisation requirements and with sunset dates in 2015.

A total of 802 substance inspections were completed. These consisted of both onsite and

desktop inspections. A questionnaire was completed for each substance inspected.

Further details on the results may be found in chapter E.

The inspected companies were selected for inspections of substances subject to

authorisation requirements and with sunset dates in 2015 based on the data provided in

their dossiers, e.g. pre-registrations, registrations, registrations of transported isolated

intermediates, applications for authorisation, substance in articles, inquiries, and CLP

notifications.

2. Coordination of the project

A Forum WG “Second Forum Pilot Project on Authorisation” was responsible for managing

this pilot project.

This included:

- providing the pilot project national coordinators (NCs) with all relevant project

documents (e.g. manual and questionnaire),

- conducting the webinar for NCs in November 2015,

- staying in close communication with them using a secure messaging system PD-NEA,

(RIPE in the past). All exchange of confidential information such as data and

inspection reports was done through PD-NEA,

- collecting and compiling the inspection findings,

- project coordination at European level with the MSs participating in the project,

- evaluating the project’s findings, and

- reporting to the Forum.

The ECHA Secretariat supported the project management, prepared data and the pdf

form for conducting the project and also contributed to the preparation of the manual

and the webinar for the NCs. In addition, they provided all necessary logistic,

administrative, financial and technical support as in Forum’s previous enforcement

projects.

3 AT, BE, CZ, DK, EE, DE, EL, ES, FI, FR, IE, IT, LI, LT, NL, SE and UK

Second Forum pilot project on authorisation – final report 8

3. Methods of enforcement

Inspections were carried out in accordance with the project manual guidance. The REACH

inspector initially completed a desktop inspection based on data prepared by ECHA and

submitted through PD-NEA to NCs as well as information available from other sources

(e.g. environmental permits and Member State competent authority).

The desktop inspection was followed up by an on-site inspection at the manufacturer,

importer or downstream user’s premises if the inspectors deemed it appropriate to seek

further evidence regarding the placing on the market or use of substances subject

to authorisation with their sunset dates in 2015.

In cases where the downstream user was in another MS, the NEA considered referring

the matter/relevant information to the appropriate NEA for follow up. This was done

using any suitable mode of bilateral information exchange using a secure exchange

e.g. PD-NEA. A questionnaire was completed for each substance subject to a desktop

or onsite inspection.

E. Results and conclusions

1. General overview

1.1. Overview of the number of inspections

17 countries participated in the pilot project with a total of 802 inspections completed.

This consisted of 359 onsite inspections and 443 desktop inspections. Questionnaires

were completed for 802 inspections of substances. Table 1 details the number of

inspections completed by participating Member States.

Table 1: Participating countries and reported inspections

Country Number of submitted inspection reports4

1 Austria 7

2 Belgium 37

3 Czech Republic 19

4 Denmark 120

5 Estonia 30

6 Finland 13

7 France 21

8 Germany 40

9 Greece 50

10 Ireland 26

11 Italy 162

12 Liechtenstein 6

13 Lithuania 25

14 Netherlands 48

15 Spain 76

16 Sweden 106

17 United Kingdom 16

Σ 802

4 Some countries indicated that they inspected more companies but based on the first results (no activities with the inspected substances) did not continue and did not fill in the questionnaire.

Second Forum pilot project on authorisation – final report 9

Section 1 of the questionnaire provided information in relation to the type of company

inspected based on the NACE-Code (Statistical classification of economic activities), the

size of the company, the role of the company and details of the substance subject to

authorisation, which was the subject of the inspection. The results detailed below are

based on the information provided by the participating Member States in the

questionnaires associated with the 802 inspections of substances completed.

1.2. NACE codes of the inspected companies

Table 2 summarises the findings of question 1.4 of the questionnaire which sought to

specify the type of business sector (based on the NACE-Code) of the companies

inspected within the scope of the project.

In terms of the NACE-Code system, the majority of the companies belonged to two types

of business sector: 367 companies (46 %) fall into the category ‘manufacturing of

chemicals and chemical products’ (NACE Code 20.00-28.89). 41 % of companies

inspected fall into the category ‘Wholesale and retail’ (NACE Code 45.00 – 47.99).

Table 2: Main business sectors of the companies inspected in the scope of the project.

NACE identifier

NACE category Number of companies Proportion of companies (N=802)

20.00-28.89 Manufacturing of chemicals and chemical products

367 46%

45.00-47.99 Wholesale and retail 332 41%

1.3. Size of the inspected companies

Companies of all size categories according to the EU5 standard scale were included in the

inspections. Table 3 summarises the findings of question 2 of the questionnaire which

sought to determine the size of the companies inspected.

Micro, small and medium-sized companies (SMEs) represented 78 % of the companies

inspected. The inspected companies were selected for inspection of substances based on

the data provided in their dossiers, e.g. pre-registrations, registrations, registrations of

transported isolated intermediates, applications for authorisations, substance in articles,

inquiries, and CLP notifications.

Table 3: Company sizes determined according to Commission Recommendation

2003/361/EC.

Company size category %

(N =802) Number of companies

Micro 22 180

Small 33 261

Medium 23 184

Σ SME 78 625

Non-SME 18 148

Not known 4 29

5 Commission Recommendation 2003/361/EC

Second Forum pilot project on authorisation – final report 10

1.4. Roles of the inspected companies under REACH

Enterprises may have one or more roles in relation to authorisation provisions under

REACH: manufacturer, importer, only representative or downstream user.

Table 4 summarises the findings of the results related to question 3.3 of the

questionnaire which sought to specify the roles of the companies inspected under REACH

in relation to the authorised substance subject to inspection. The role of the company

(at least one) was stated for only 25 % of the substances inspected (for 207 substances

inspections). Eight companies reported having more than one role (it is possible for

a company to have multiple roles). 20 % of the companies inspected have a downstream

user role in the supply chain (157 out of 802). 603 of the companies inspected had no

present role.

Table 4: Company roles under REACH (present role).

Company roles under REACH Number of companies

(N = 207)

Manufacturer (M) 4

Importer (I) 37

Only representative (OR) 9

Downstream user (DU) 157

2. Number of companies inspected, per substance subject to

inspection.

Table 5 summarises the findings of the results related to question 3.1 of the

questionnaire. Question 3.1 asked the inspector to specify which substance was the

subject of inspection.

Table 5: Number of inspections related to inspected substance. No Substance subject of inspection EC number Number of inspections

related to substance

1 Diisobutyl phthalate (DIBP) 201-553-2 80

2 Dibutyl phthalate (DBP) 201-557-4 119

3 Benzyl butyl phthalate (BBP) 201-622-7 83

4 Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 119

5 Diarsenic pentaoxide 215-116-9 7

6 Diarsenic trioxide 215-481-4 33

7 Lead sulfochromate yellow (C.I. Pigment Yellow 34)

215-693-7 121

8 Lead chromate molybdate sulphate red

(C.I. Pigment Red 104)

235-759-9

87

9 Lead chromate 231-846-0 36

10 Tris(2-chloroethyl)phosphate (TCEP) 204-118-5 31

11 2,4 Dinitrotoluene (2,4-DNT) 204-450-0 13

12 Hexabromocyclododecane (HBCDD), alpha-exabromocyclododecane, beta-hexabromocyclododecane, gamma-

hexabromocyclododecane

221-695-9, 247-148-4

62

13 DBP + DEHP 201-557-4 + 204-211-0 11

Σ 802

The table in Annex 1 summarises the findings of the results related to question 3.2 of the

questionnaire (the specific use of the substance).

Second Forum pilot project on authorisation – final report 11

3. Number of inspected companies placing a substance subject to inspection on the market after its sunset date.

Table 6 summarises the findings of the results in relation to question 4 of the

questionnaire (Has the company as a manufacturer, importer or downstream user placed

the substance subject to inspection on the market for use after its sunset date defined

in Annex XIV?).

A total of 802 substance inspections were completed. In 735 cases (92 %), the

substances inspected were not placed on the market for use after their sunset date.

The substances subject to authorisation in those cases were not present in the

companies (even if companies pre-registered the substance) or the companies were not

placing substances on the market after the sunset date.

In 67 cases, it was found that the substances subject to inspection were placed on the

market by the companies after the sunset date. Six companies were identified as being

in breach of the REACH Regulation. In one case, there was a non-compliance with the

authorisation granted. This represents a non-compliance rate of 8.9 % of cases where

the substance was placed on the market.

The non-compliance for all inspected substances was low – approximately 0.7 %.

In 16 cases, companies placed substances on the market based on the authorisation

granted. In an additional 16 cases, the companies placed the substances inspected on

the market based on a pending authorisation decision at the time of inspection. The

decisions on these substances are still pending and the companies are therefore deemed

to be in compliance on this issue.

There were 30 cases where companies placed substances on the market for an exempted

use. The exempted uses are broken down as follows, four exempted cases based on use

as an intermediate, one case for use in medicinal products, 17 cases for scientific

research, one case for use below a concentration limit of 0.1% weight by weight and

seven cases for other reasons (multiple responses were possible).

Second Forum pilot project on authorisation – final report 12

Table 6: Number of inspected companies placing a substance on the market and applied exemption. No Substance subject of inspection Number of

inspections

where substances were placed on the market

Number of inspections where

substances were not placed on the market

Number of inspections where substances were

placed on the market based on an authorisation granted

Number of inspections where

inspected substances were placed on the market for the exempted uses

Number of inspections

where substances were placed on the market based on an pending authorisation

Number of the inspections

where inspected substances were in breach

1 Diisobutyl phthalate (DIBP) 3 77 0 3 0 0

2 Dibutyl phthalate (DBP) 10 109 3 4 0 3

3 Benzyl butyl phthalate (BBP) 2 81 0 2 0 0

4 Bis(2-ethylhexyl) phthalate (DEHP) 10 109 0 7 3 0

5 Diarsenic pentaoxide 1 6 0 1 0 0

6 Diarsenic trioxide 5 28 1 4 0 0

7 Lead sulfochromate yellow (C.I. Pigment Yellow 34) 14 107 5 2 7 16

8 Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 13 74 5 2 6 0

9 Lead chromate 1 35 0 1 0 0

10 Tris(2-chloroethyl)phosphate (TCEP) 1 30 0 1 0 0

11 2,4 Dinitrotoluene (2,4-DNT) 1 12 0 1 0 0

12 Hexabromocyclododecane (HBCDD), alpha-exabromocyclododecane, beta-hexabromocyclododecane, gamma-hexabromocyclododecane 5 57 2 1 0 2

13 DBP + DEHP 1 10 0 1 0 0

Σ 67 735 16 30 16 6

6 In one case, there was a non-compliance with the authorisation granted

Second Forum pilot project on authorisation – final report 13

4. Number of inspected companies using a substance subject to inspection and applied exemption

Table 7 summarises the findings of the results in relation to question 5 of the

questionnaire (Does the company use the substance subject to inspection for which its

sunset date has passed in 2015?).

746 of the 802 substances inspected were not used after their sunset date. Inspections

have shown that, in most of those cases, the substances were e.g. not used for many

years or after the sunset date; eliminated from the production cycle; used in the past for

scientific research; only pre-registered as a precautionary measure; notified (through

bulk notification) by parent companies centrally although the substance in question was

never intended to be used in the MS.

56 companies used substances with a sunset date that had passed in 2015. Six of these

companies were found to be in breach of Article 56 of REACH. In one case, there was

a non-compliance with the authorisation granted. This represents a non-compliance rate

of 10.7 % of cases where the substance was used after the sunset date.

The non-compliance for all inspected substances was low - approximately 0.7 %.

12 companies used the substance based on an authorisation granted to the company

inspected. 16 companies used the substance based on an authorisation granted to an

actor up the supply chain for that use. 10 of the companies inspected were using the

substances subject to authorisation based on a pending decision in relation to an

application for authorisation at the time of inspection. The decisions on these substances

are still pending and the companies are, therefore, deemed to be in compliance on this

issue.

There were 13 cases identified where companies used a substance subject to

authorisation after its sunset date for an exempted use. The exempted uses are broken

down as follows: one case based on use as an intermediate, one case for use in medicinal

products, four cases for scientific research, two cases for use in food contact materials,

and five cases for other reasons (multiple responses were possible).

Second Forum pilot project on authorisation – final report 14

Table 7: Number of inspected companies using a substance and applied exemption. No Substance subject of inspection Number of

inspection

where companies used inspected substance

Number of inspections

where companies did not use inspected substance

Number of inspections where

companies used inspected substance based on an authorisation granted to the company

inspected

Number of inspections where

companies used substance based on an authorisation granted to an actor up the supply chain for

that use

Number of inspections

where companies used inspected substance for the exempted uses

Number of inspections

where companies used substance based on an pending authorisation

Number of the

inspections were inspected substances were in breach

1 Diisobutyl phthalate (DIBP) 0 80 0 0 0 0 0

2 Dibutyl phthalate (DBP) 9 110 1 4 2 0 27

3 Benzyl butyl phthalate (BBP) 0 83 0 0 0 0 0

4 Bis(2-ethylhexyl) phthalate (DEHP) 10 109 0 0 7 3 0

5 Diarsenic pentaoxide 0 7 0 0 0 0 0

6 Diarsenic trioxide 4 29 1 0 1 0 2

7 Lead sulfochromate yellow (C.I. Pigment Yellow 34) 16 105 4 6 1 5 18

8 Lead chromate molybdate

sulphate red (C.I. Pigment Red

104) 11 76 4 4 1 2 0

9 Lead chromate 0 36 0 0 0 0 0

10 Tris(2-chloroethyl)phosphate (TCEP) 0 31 0 0 0 0 0

11 2,4 Dinitrotoluene (2,4-DNT) 0 13 0 0 0 0 0

12 Hexabromocyclododecane (HBCDD), alpha-exabromocyclododecane, beta-hexabromocyclododecane,

gamma-hexabromocyclododecane 5 57 2 2 0 0 1

13 DBP + DEHP 1 10 0 0 1 0 0

Σ 56 746 12 16 13 10 6

7 In one case, there was a breach of Article 56(2) of REACH since the company did not follow the risk management measures given in the chemical safety report and in the

authorisation decision. 8 In one case, there was a non-compliance with the authorisation granted

Second Forum pilot project on authorisation – final report 15

5. Number of non-compliances

This paragraph summarises the findings of questions 6-9 of the questionnaire. These

questions related to non-compliances in the companies inspected in relation to the

following Articles of REACH:

- Article 56(1) - placing the substance subject to inspection on the market or use without

authorisation

- Article 56(2) - using the substance subject to inspection in accordance with the

conditions of a granted authorisation to an actor up to the supply chain for that use

- Article 65 - including the authorisation number on the label

- Article 66(1) - notification of downstream users using the substance in accordance with

Article 56(2)

There were 12 non-compliances with REACH cases (most of the non-compliant

substances were in breach of two or more REACH articles) noted as part of the 802

substance inspections completed in this pilot project: six in relation to Article 56(1),

seven in relation to Art 56(2)9, four in relation to Article 65 and two in relation to Article

66(1) (multiple responses).

6. Number and kind of legal action initiated against the offender

This paragraph summarises answers to question number 10 of the questionnaire.

There were 13 legal actions initiated: three verbal advices10, five written advices and four

administrative orders issued. In two cases, a criminal complaint/handing over to the

public prosecutor was undertaken and in five cases follow up activities are still on-going

(multiple responses).

7. Number of cases forwarded to other Member States and the identity of the receiver of the information

This paragraph summarises answers to question number 11 of the questionnaire.

Information was forwarded to another MS in three cases for follow up.

8. Enforceability of the authorisation decision/succinct summary

This paragraph summarises answers to question number 12 of the questionnaire related

to enforceability of the conditions referenced or provided in the authorisation decision

with the potential use of the succinct summary once the authorisation was granted.

Question 12 was only answered for 18 inspections.

In nine cases, it was found that the information about the conditions in the actual

authorisation decision enabled good enforceability of the authorised uses. In those nine

cases, the succinct summary was: not available in three cases, not needed in five cases

and not checked by inspector in one case.

For the remaining nine cases the information in the authorisation decision did not provide

any additional assistance in relation to enforcement.

9 One company did not follow the risk management measures given in the chemical safety report and in the

authorisation decision. 10 In one case, the substance is not used from 2010 but the company had it in stock. Following a verbal advice,

the stocked substance was correctly disposed.

Second Forum pilot project on authorisation – final report 16

The succinct summary was used during the inspection of the authorised use in only two

cases. The following difficulties were identified in relation to the enforcement of the

operational conditions and risk management measures required in the authorisation

decision (using information in the authorisation decision and/or succinct summary):

- Authorisation was pending;

- Substance supplied from a non-EU source. This made it difficult to monitor the

downstream users who are primarily based in the construction industry. The

safety data sheet was not updated since authorisation;

- In the authorisation decision, there is a reference to circumstances of use, risk

management measures and monitoring presented in the authorisation application

and chemical safety assessment. This reference is not always workable in

practice. The succinct summary of circumstances of use and risk management

measures would make enforcement easier.

F. Recommendations

Recommendations are based on the experience of the members of the Working Group as

well as on the results of the project and on the feedback from the questionnaires

completed by the national coordinators.

1. Recommendations to the Forum

Further pilot or REF project on authorisation for substances whose sunset dates

have passed. During this project, the succinct summaries were inspected only on

very few occasions. It would be beneficial to gain more experience with enforcing

authorisation decisions and the underlying conditions.

2. Recommendations to enforcement authorities and inspectors

National coordinators to report the results back to the Working Group within the

timeframe set out in the manual to ensure overall project deadlines are achieved

in line with the activity plan. Follow up in Member States with national projects on

authorisation for substances whose sunset dates have passed.

3. Recommendations to industry

Implement appropriate operational controls and risk management measures as

set out in the authorisation decision for any authorised substance in use past its

sunset date.

4. Recommendation to the Commission

Provide clarification in relation to only representative status with regard to

authorisation decisions of the Commission.

List of annexes:

Annex 1: Responses to question 3.2 of the questionnaire

Annex 2: Table 1: List of substances included in Annex XIV to REACH ("Authorisation

List") with their sunset dates in 2015

Annex 3: Questionnaire

Second Forum pilot project on authorisation – final report 17

Annex 1: Responses to question 3.2 of the questionnaire The Annex 1 summarises the findings of the results related to question 3.2 of the questionnaire (the specific use of the substance) No EC number Types of use

1 201-553-2 - Activator - Additive - Formulation - Formulation in compounds as denaturant - Formulation of granules of plastic material containing DIBP to produce plastic articles - Formulation of granules of PVC containing DIBP to produce PVC articles - Formulation of plastic material containing DIBP to produce articles

- Hardener - Industrial use of recycled soft PVC containing DEHP in polymer processing by calendering, extrusion, compression and injection

moulding to produce PVC articles - plasticizer - plasticizer for paints and varnishes - Protective coating

- Scientific research - Solvent (polyester catalyst) - substance on its own and in a mixture - to denature/to adulterate the mixtures - to produce pigmented paste for wood industry paints

- Transported isolated intermediate used in a catalyst. - Used as a plasticizer in coatings for metals

2 201-557-4 - Additive - Additive Plasticizer and softening agent for the leather sector - Adhesive plasticizer for glue - Ceramic products. Decoration for tiles and bonding for decoration - Chemical injection mass

- component for paraffin wax remover - component of a thermoplastic resin - Fishing bait - Formulation - Formulation of a glue used in the Aerospace Industry

- Formulation of decoration products for glass - Formulation of granules of plastic material containing DBP to produce plastic articles

- Industrial use of DBP in ceramic sheets and printing pastes for production of capacitors and lambda sensor elements - Inspection following CLP-notification - plastic - Plasticiser in paint manufacturing - plasticizer - Plasticizer additive for polymers

Second Forum pilot project on authorisation – final report 18

- Plasticizer paint used in coatings for metals

- priming plasticiser for construction - Production / distribution of solvent mixtures - production of mixtures used in tanning

- Propellant powder - resale - Research and Development - resins and paints plasticiser - scientific research - solution for the manufacturing of maleic anhydride. - substance in mixture

- the substance is Used in two-component mixtures with functions of "hardening"

- to produce paints for the wood industry - Transported isolated intermediate - Transported isolated intermediate used in a catalyst. - Use in propellant powders - Use in reaction bath - Use of DBP-containing propellant grains in manufacture of ammunition.

- Used as a plasticizer in coatings for metals - Used as raw material in the production of articles like hoses and cables in cars - wintering machine propulsion

3 201-622-7 - Activator - Additive

- chemical mixture (inkt)

- component of sealant - Fishing bait - Formulation - Formulation of granules of plastic material containing BBP to produce plastic articles - plasticizer for paints and varnishes - Plasticizer. Raw material in mixture used for the inner lining of tanks

- scientific research - to produce paints for the wood industry

4 204-211-0 - Additive - articles - chemical mixture

- Cleaning.

- Component of a film for decorating injected plastic parts - DEHP formulation in mixtures, dry mixtures and Plastisol formulations. - Epoxy filler component bi-component for boating - Fishing bait - Formulation of decoration products for glass - Formulation of DEHP in compounds for ceramic sheets and printing pastes for production of ceramic elements and tiles for build

constructions - Formulation of DEHP in compounds, dry-blends and Plastisol formulations

Second Forum pilot project on authorisation – final report 19

- Formulation of granules of plastic material containing DBP to produce plastic articles

- Industrial use for PVC articles precursors - industrial use in chemical product - Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles

[except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)]

- Industrial use in polymer processing by calendering, spread coating, extrusion, injection moulding to produce PVC articles [except erasers, sex toys, small household items (<10cm ) that can be swallowed by children, clothing intended to be worn against the bare skin; also toys, cosmetics and food contact material (restricted under other EU regulation)]

- Industrial use of plastic material containing DEHP in polymer processing by calendering, extrusion, compression and injection moulding to produce plastic articles

- Ingredient; precatalyst in polymerization; intermediate

- Intermediate - marginal use in paints and coatings - Medical Device - Medical Device - mixture (food packaging) - Plasticizer

- Plasticizer additive for elastomers and technical plastics - plasticizers for the formulation of colored masterbatch - presumed use as plasticizer - production of mixtures used in tanning - Scientific research - substance on its own and in a mixture

- The substance was only pre-registered as a precautionary measure. - to denature/to adulterate the mixtures - to produce pigmented paste for wood industry paints - Transported isolated intermediate used in a catalyst. - unclear; inspection after CLP notification - Used as plasticizer in medical devices - Used in articles like hoses and cables in cars

- Was used as a plasticizer; use stopped in 2012

5 215-116-9 - Adjusting acidity in ore concentrating - Scientific research

6 215-481-4 - For formulators of paint

- Formulation of diarsenic trioxide into a mixture

- Formulation of diarsenic trioxide into a mixture. Reagents for laboratory - Scientific research - semiconductors production - substance on its own and in a mixture - They sell it to the pharmaceutical industry that use it as a reference standard in their analysis - Use of diarsenic trioxide in the purification of metal impurities from the leaching solution in the zinc electrowinning process.

7 215-693-7 - colouring of glassware under 1935/2004 (food contact material) - Component for the manufacturing of plastic sheets.

Second Forum pilot project on authorisation – final report 20

- Distribution and mixing pigment powder in an industrial environment into solvent-based paints for non-consumer use - "Use 1"

- Distribution and mixing pigment powder in an industrial environment into liquid or solid premix to colour plastic/plasticised articles for non consumer use - "Use 4"

- dye in the paint

- Dye plastics - formulation into paints for road marking - Formulation of granules of plastic material containing Pigment Yellow 34 to produce plastic articles - Formulation of mixtures - formulator of paints for road marking - Industrial application of paints on metal surfaces (such as machines vehicles, structures, signs, road furniture, coil coating etc.)-

"Use 2"

- industrial use for the mixture preparation

- Industrial use of solid or liquid colour premixes and pre-compounds containing pigment to colour plastic or plasticised articles for non-consumer use) - "Use 5"

- mixing pigment powder in an industrial environment into solvent based paints for non consumer use. - Paint and coating - paint pigment - Pigment

- pigment for paint - pigment for paints for the wood industry - Pigment used in paint formulation. - pigments in the manufacture of colored masterbatch - production of mixtures used in tanning - Professional, non-consumer application of paints on metal surfaces (such as machines, vehicles, structures, signs, road furniture

etc.) or as road marking) - "Use 3" - road marking - Scientific research - the company does not use the substance - The substance was only pre-registered as a precautionary measure. - use as pigment in article; use stopped before sunset date - use as pigment in mixture; stopped before sunset date

- Use in formulation of mixtures for coloring plastics for industrial use - waste potentially containing the substance transformed in end-of-waste produce

8 235-759-9 - Distribution and mixing pigment powder in an industrial environment into solvent-based paints for non-consumer use - "Use 1" - Industrial application of paints on metal surfaces (such as machines vehicles, structures, signs, road furniture, coil coating etc.)-

"Use 2" - colouring of glassware under 1935/2004(food contact material)

- Distribution and mixing pigment powder in an industrial environment into liquid or solid premix to colour plastic/plasticised articles for non consumer use - "Use 4"

- dye in the paint - Formulation of granules of plastic material containing Pigment Red 104 to produce plastic articles - industrial use for the mixture preparation - Industrial use of solid or liquid colour premixes and pre-compounds containing pigment to colour plastic or plasticised articles for

non-consumer use) - "Use 5"

Second Forum pilot project on authorisation – final report 21

- mixing pigment powder in an industrial environment into solvent based paints for non consumer use.

- Paint and coating - Pigment - pigment for paint

- pigment for paints for the wood industry - Pigment used in paint formulation. - pigments in the manufacture of colored masterbatch - Professional, non-consumer application of paints on metal surfaces (such as machines, vehicles, structures, signs, road furniture

etc.) or as road marking) - "Use 3" - Sale of pigment. - Scientific research

- The substance was only pre-registered as a precautionary measure.

- use as pigment in article; stopped before sunset date - use as pigment in mixture; stopped before sunset date - Use in formulation of mixtures for coloring plastics for industrial use

9 231-846-0 - detonators production - Distribution and mixing pigment powder in an industrial environment into solvent-based paints for non-consumer use - "Use 1"

- Formulation for decoration products for production of ceramic elements and tiles for build constructions - Formulation of granules of plastic material containing Pigment Red 104 to produce plastic articles - formulation to colour plastic - Industrial application of paints on metal surfaces (such as machines vehicles, structures, signs, road furniture, coil coating etc.)-

"Use 2" - Pigment

- pigment for paints for the wood industry

- Professional, non-consumer application of paints on metal surfaces (such as machines, vehicles, structures, signs, road furniture etc.) or as road marking) - "Use 3"

- Scientific research

10 204-118-5 - Additive (plasticiser / flame retarding s.) - flame retardant

- industrial use in chemical product - Scientific research - The substance was only pre-registered as a precautionary measure. - Was used as a flame retardant; use stopped in 2010

11 204-450-0 - Additive

- Moderator for powders

- Propellant powder - Scientific research - use for explosives and ammunition

12 221-695-9, 247-148-4

- Additive to fire retardant - EPS

- flame retardant - Flame retardant in EPS - Flame retardant in thermal insulation boards. - Formulation of flame retarded expanded polystyrene (EPS) to solid unexpanded pellets using hexabromocyclododecane as the

Second Forum pilot project on authorisation – final report 22

flame retardant additive (for onward use in building applications)

- formulation of flame retarded of masterbatche electric cables - inspection following suspicion of HBCDD use to form articles - Insulation Products

- light concrete with recycling EPS - Manufacture of flame retarded expanded polystyrene (EPS) articles for use in building applications." - Molding of self-extinguishing parts - production of flame retarded EPS (pellets and articles) - Scientific research

13 201-557-4 +

204-211-0

- additive

- plasticiser - Scientific research and development

Second Forum pilot project on authorisation – final report 23

Annex 2: List of substances included in Annex XIV to REACH ("Authorisation List") with their sunset dates in 201511.

Name EC Number

CAS Number Sunset date Latest application date

Number of

AfAs12

received

Opinions delivered (per Use)

Decision taken (per AfA)

Date of submission of opinions to COM (AfA)

Timeline of decisions

(AfA)13

Diisobutyl phthalate (DIBP) 201-553-2 84-69-5 21 February 2015 21 August 2013 0 0 0 N/A N/A

Dibutyl phthalate (DBP) 201-557-4 84-74-2 21 February 2015 21 August 2013 2 4 2 Apr 2014 (1) Dec 2014 (1)

Dec 2014 (1) April 2016 (1)

Benzyl butyl phthalate (BBP) 201-622-7 85-68-7 21 February 2015 21 August 2013 0 0 0 N/A N/A

Bis(2-ethylhexyl) phthalate (DEHP) 204-211-0 117-81-7 21 February 2015 21 August 2013 5 14 2 Jan 2014 (1) Oct 2014 (3) Feb 2015 (1)

Aug 2014 (1) June 2016 (1)

[DBP + DEHP] 201-557-4 204-211-0

84-74-2 117-81-7

21 February 2015 21 August 2013 1 3 1 June 2014 (1) March 2015 (1)

Diarsenic pentaoxide 215-116-9 1303-28-2 21 May 2015 21 November 2013 0 0 0 N/A N/A

Diarsenic trioxide 215-481-4 1327-53-3 21 May 2015 21 November 2013 4 5 4 Oct 2014 (3)

Jan 2015 (1)

Sept 2015 (3)

May 2015 (1)

Lead sulfochromate yellow (C.I. Pigment Yellow 34)

215-693-7 1344-37-2 21 May 2015 21 November 2013 1 (covering both pigments)

12 1 Jan 2015 (1) Sept 2016 (1)

Lead chromate molybdate sulphate red (C.I. Pigment Red 104)

235-759-9 12656-85-8 21 May 2015 21 November 2013

Lead chromate 231-846-0 7758-97-6 21 May 2015 21 November 2013 1 1 0 Sept 2015 (1)

Tris(2-chloroethyl)phosphate (TCEP)

204-118-5 115-96-8 21 August 2015 21 February 2014 0 0 0 N/A N/A

2,4 – Dinitrotoluene (2,4-DNT) 204-450-0 121-14-2 21 August 2015 21 February 2014 0 0 0 N/A N/A

Hexabromocyclododecane (HBCDD), alpha-hexabromocyclododecane, beta-hexabromocyclododecane, gamma-hexabromocyclododecane

221-695-9 247-148-4

134237-50-6 134237-51-7 134237-52-8 25637-99-4 3194-55-6

21 August 2015 21 February 2014 1 2 1 Jan 2015 (1) Jan 2016 (1)

11 http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/recommendation-for-inclusion-in-the-authorisation-list/authorisation-list 12 Application for Authorisation 13 This information is regularly updated and available on ECHA website at: http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/applications-for-

authorisation/received-applications and on COM website http://ec.europa.eu/growth/sectors/chemicals/reach/about/index_en.htm

Second Forum pilot project on authorisation – final report 24

Annex 3: Questionnaire on the Forum second pilot

project on authorisation QUESTIONNAIRE

(One (1) questionnaire per substance per inspected company)

0. Section – General Information about the inspection (questions 0.2 to 0.5 will not be recorded)

0.1.Participating country:

0.2. Authority:

0.3. Person in Charge:

Telephone:

Fax:

E-mail:

0.4. Date of inspection:

0.5. File reference:

Only for internal use – do

not submit data

0.6. Type of inspection

⃝ Only desk top check

⃝ On-site check

I. Section – General information about the inspected company

(questions 1.1. to 1.3. will not be recorded) 1.1. Name of company:

1.2. Name and telephone of the contact person: 1.3. Contact person’s qualification:

Only for internal use – do

not submit data

1.4. Company’s NACE-Code(s): Source for NACE Code see

Annex 5, please provide 4-digit NACE class, e.g. "01.11"

2. According to Commission Recommendation 2003/361/EC the company qualifies as:

⃝ Micro ⃝ Small ⃝ Medium ⃝ not SME ⃝ unknown

Micro: <10 employees and ≤2 million euro annual turnover Small: <50 employees and ≤10 million euro annual turnover

Medium: <250 employees and ≤50 million euro annual turnover Not SME: >250 employees and > 50 million euro annual turnover

Second Forum pilot project on authorisation – final report 25

3.1. Specify which substance is subject to inspection according to

EC number:

⃝ 201-553-2 Diisobutyl phthalate (DIBP)

⃝201-557-4 Dibutyl phthalate (DBP)

⃝201-622-7 Benzyl butyl phthalate (BBP)

⃝204-211-0 Bis(2-ethylhexyl) phthalate (DEHP)

⃝215-116-9 Diarsenic pentaoxide

⃝215-481-4 Diarsenic trioxide

⃝215-693-7 Lead sulfochromate yellow

(C.I. Pigment Yellow 34)

⃝235-759-9 Lead chromate molybdate sulphate red

(C.I. Pigment Red 104)

⃝231-846-0 Lead chromate

⃝204-118-5 Tris(2-chloroethyl)phosphate (TCEP)

⃝204-450-0 2,4 Dinitrotoluene (2,4-DNT)

⃝221-695-9, 247-148-4

Hexabromocyclododecane (HBCDD), alpha-hexabromocyclododecane, beta-hexabromocyclododecane, gamma-hexabromocyclododecane

⃝201-557-4 + 204-211-0 (DBP + DEHP)

3.2. Specify the use(s) of the substance

………… 3.3. Roles of the company under REACH in relation to the

substance subject to inspection with its sunset date in 2015:

Manufacturer

Importer (company not covered by an OR)

Only Representative (OR)

Downstream User (e g: formulator, producer of an

article, importer covered by an OR, end-user)

No present role for the inspected substance (further

details are reported in section V)

3.1. Note

Only one substance per

company per questionnaire.

If more substances are checked

per company then additional

questionnaires should be filled

in.

3.2. Note

Please check the Annex 6

column H

3.3 Note:

Art 3.9 of REACH

Art 3.11 of REACH

Art 8.1 of REACH

Art 3.13 of REACH

Second Forum pilot project on authorisation – final report 26

II. Section - Compliance with authorisation duties by the company

4. Has the company as M, I or DU placed the substance subject to inspection (mentioned in Q3) on the market for use after its sunset date defined in Annex XIV?

⃝ Yes,

as substance as such, in mixtures or to be included in articles

based on an authorisation granted

as substance as such, in mixtures or to be included in articles

as substance as such, in mixtures or to be included in articles

based on the exemptions

If the use of the substance is exempted, specify the reason

Exempted uses

On-site isolated intermediate / transported isolated

intermediate

Use in medicinal products and/or the immediate packaging

of medicinal products

Use in food or feeding stuffs

Use in scientific research

Use on plant protection products

Use in biocidal products

Use as motor fuel

Use as fuel in combustion plants of mineral oil products

Use in cosmetic products

Use in food contact materials

Use of substances referred in Article 57 d, e, and f when

present in mixtures below a concentration limit of 0.1%w/w

Use of substances when present in mixtures below the

lowest of the concentration limits specified in Directive 1999/45/EC or in Part 3 of Annex VI to Regulation (EC) No.

1272/2008 which results in classification of the mixture as dangerous

Others (e.g. substance in articles):

Please specify.

⃝ No

Note: Art 56 of REACH

Please give here the Exemption(s) that is (are) the most relevant in the situation of the company. For exemptions, see in Annex 1.

Please note that a manufacturer, importer

or a downstream user may place a substance on the market for a use, for which he does not

have an authorisation itself. In such a case the authorisation had to be granted for that use to its immediate downstream user in the

supply chain. For example: In a case where a formulator has an authorisation for formulating a substance, the manufacturer may

place the substance on the market for the formulation by the formulator despite the manufacturer not having an authorisation itself.

5. Does the company use the substance subject to inspection (mentioned in Q3) for which its sunset date has passed in 2015?

⃝ Yes,

as substance as such, in mixtures or to be included in articles

based on an authorisation granted to the company inspected

as substance as such, in mixtures or to be included in articles

based on an authorisation granted to an actor up the supply chain for that use

Note: Art 56 of REACH

Please give here the Exemption(s) that is (are) the most relevant in the situation of the company. For

exemptions, see in Annex 1.

Second Forum pilot project on authorisation – final report 27

as substance as such, in mixtures or to be included in articles

as substance as such, in mixtures or to be included in articles

based on the exemptions

If the use of the substance is exempted, specify the reason

On-site isolated intermediate / transported isolated

intermediate

Use in medicinal products and/or the immediate packaging

of medicinal products

Use in food or feeding stuffs

Use in scientific research

Use on plant protection products

Use in biocidal products

Use as motor fuel

Use as fuel in combustion plants of mineral oil products

Use in cosmetic products

Use in food contact materials

Use of substance referred in Article 57 d, e, and f when

present in mixtures below a concentration limit of 0.1%w/w

Use of substance when present in mixtures below the

lowest of the concentration limits specified in Directive 1999/45/EC or in Part 3 of Annex VI to Regulation (EC) No. 1272/2008 which results in classification of the mixture as dangerous

Others (e.g. substance in articles):

Please specify.

⃝ No

Second Forum pilot project on authorisation – final report 28

III. Section – Summary / action (company related)

6. Has non-compliance with REACH obligations of the inspected company related to Art 56 (1) of REACH (placing the substance subject to inspection on the market or use without authorisation) been detected?

⃝ Yes

⃝ No

7. Has non-compliance with REACH obligations of the inspected company related to Art 56 (2) of REACH (using the substance subject to inspection in accordance with the conditions of a granted authorisation to an actor up to his supply chain for that use) been detected?

⃝ Yes

⃝ No

8. Has non-compliance with REACH obligations of the inspected company related to Art 65 of REACH

(including the authorisation number on the label) been detected?

⃝ Yes

⃝ No

9. Has non-compliance with REACH obligations of the inspected company related to Art 66 (1) of REACH (notification of DUs using the substance in accordance with Article 56 (2)) been detected?

⃝ Yes

⃝ No

10. Was legal action initiated against the offender?

⃝ Yes

If yes,

Verbal advice

Written advice

Administrative order

Fine

Criminal complaint / handing over to public prosecutor's office

Other:

Follow up activities still on-going

⃝ No

11. Has information related to the inspected substance been forwarded to another Member States?

⃝ Yes

If yes,

National Enforcement Authority

National Competent Authority

Forum Member

National Pilot Project Coordinator

NEA Contact Point / Focal Point in RIPE

Feedback from the other Member State approached is already available

⃝ No

Second Forum pilot project on authorisation – final report 29

IV. Section – Enforceability of the authorisation decision/succinct

summary 12.1 Once an authorisation has been granted: have the actual

authorisation conditions referenced or provided in the authorisation

decision (Note 1.) enabled good enforceability of the authorised uses(s) (including general conditions, monitoring arrangements, the required risk management measures and operational conditions of the exposure scenarios)?

⃝ Yes

⃝ No

If no, please specify difficulties in enforceability of the conditions

required in the authorisation decision: …

⃝ Not relevant

12.2. Once an authorisation has been granted: was the succinct summary

(Note 2.) used during the inspection of the authorised use(s)?

⃝ Yes

If yes,

information was appropriate to easily enforce the

authorisation decision

information was not appropriate to easily enforce the

authorisation decision

other: …

Please specify what kind of information was missing in the succinct summary in order to easily enforce the authorisation decision: …

⃝ No

If no,

succinct summary was not available

succinct summary was no needed

other:….

Note: The intention of this question

is to answer only if the authorisation is granted. 1. For downstream users

supplied with the authorised substance, the authorisation conditions of

the authorisation decision are communicated in the extended safety data sheet. In such cases it is important that the

inspector checks that the relevant content of the

extended safety data sheet is in line with the conditions of the authorisation decision (e.g. whether the content of the relevant exposure

scenarios in the extended safety data sheet and in the authorisation decision do match in terms of content)

2. According to the requirements of

authorisation decisions the

Member States can ask to have the succinct summary available in their official language(s) 14

V. Section – Informal comments15

13.………………………………………………………………………………………………………………………………………………………………………

………………………………………………………………………………………………………………………………………………………………………

…………………………………………………………………………………………..............

14 http://echa.europa.eu/documents/10162/13552/afa_inst_format_succint_summary_rmm_oc_en.pdf 15 Please fill this section if you would like to inform on obstacles overcome, lessons learned, need for

clarification/harmonisation